Work InjuryNCT06484569
Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers
A study testing exercise and cranio sacral therapy in people with Work Injury and Work-related Illness, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Injury, Work-related Illness
- What is being tested?
- exercise and cranio sacral therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2024to 2 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 18-60 years old
- Working full time
- Experiencing neck pain
Who cannot join
- Being under 18 or over 60 years old
- Presence of diseases accompanying neck pain
- Exercise intolerance
- Working part time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers: A Randomized Controlled Trial
The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory.
Read the detailed description
The study will include workers between the ages of 18-60 who have neck pain and work at Ölmezler Textile Industry Trade limited company in Van province. Participants will be divided into two groups as experimental and control groups. All participants will receive ergonomic training. In addition, exercise training will be given to individuals in the experimental group. Exercises will be explained individually and will be supported with an exercise brochure. Craniosacral therapy will also be applied to the experimental group and a brochure will be given to teach joint protection principles. Participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. The given exercises will be followed with an exercise follow-up chart. An evaluation will be made before and after the study.
- Conditions
- Work Injury, Work-related Illness
- Being tested
- Control, exercise and cranio sacral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
The content of ergonomics training will include the definition of ergonomics, ergonomic positions and arrangements. Postural arrangements will be explained to patients individually and supported by a brochure.
exercise and cranio sacral therapyOther
Posture exercises Stretching exercises Strengthening Exercises In addition, deep tissue massage will be applied to increase blood circulation and cranio-sacral therapy will be applied to increase cerebrospinal fluid circulation.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | They will receive ergonomics training Receives: Other: Control |
| exercise | Experimental | Ergonomics training, exercise training and cranio sacral therapy will be applied Receives: Other: Control; Other: exercise and cranio sacral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bournemouth Neck Pain Survey
The survey consists of 7 questions. In addition to questions about pain and disability, it also includes questions about psychosocial issues. Each question is scored between 0 and 10. The highest score is 70, with a higher score indicating a higher level of disability. The content of the survey consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on daily life activities and social life, anxiety-depression level, kinesiophobia and coping with pain.
Measured: 14 weeks
The Fremantle Neck Awareness Questionnaire
The questionnaire is a Likert-type questionnaire (0 = Never/Never feel like this, 1 = Rarely feel like this, 2 = Sometimes or sometimes feel like this, 3 = Often feel like this, 4 = Always or most of the time feel like this) that evaluates individual-specific altered perception. The questionnaire asks individuals 9 questions such as how they perceive their neck in relation to their body, how they perceive their body position. The total score varies between 0-36. A high score indicates a poor prognosis.
Measured: 14 weeks
Fatigue Severity Scale
The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.
Measured: 14 weeks
Pittsburgh Sleep Quality Survey
The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start2 Jul 2024
- Primary completion1 Nov 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Work InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Hilal ATASOY, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484569
- Sponsor's protocol ID
- Uskudar12
- Status last verified
- Jan 2025
- First submitted
- 26 Jun 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Islam T. Health Concerns of Textile Workers and Associated Community. Inquiry. 2022 Jan-Dec;59:469580221088626. doi: 10.1177/00469580221088626.
PubMed 35604168Michaud F, Pazos R, Lugris U, Cuadrado J. The Use of Wearable Inertial Sensors and Workplace-Based Exercises to Reduce Lateral Epicondylitis in the Workstation of a Textile Logistics Center. Sensors (Basel). 2023 May 27;23(11):5116. doi: 10.3390/s23115116.
PubMed 37299843Metgud DC, Khatri S, Mokashi MG, Saha PN. An ergonomic study of women workers in a woolen textile factory for identification of health-related problems. Indian J Occup Environ Med. 2008 Apr;12(1):14-9. doi: 10.4103/0019-5278.40810.
PubMed 20040992Eraslan U, Gelecek N, Genc A. Effect of scapular muscle endurance on chronic shoulder pain in textile workers. J Back Musculoskelet Rehabil. 2013;26(1):25-31. doi: 10.3233/BMR-2012-0346.
PubMed 23411645Split W, Kotwica S, Woszczak M. [Role of exercise therapy in the prevention of lumbosacral backache in textile industry workers]. Med Pr. 1984;35(6):465-9. Polish.
PubMed 6242064Atasoy H, Sevgin O, Karamancioglu B, Dikmen Hosbas B. Ergonomics training with exercise and manual therapy in textile workers: a randomized controlled trial. Int Arch Occup Environ Health. 2025 Sep;98(7):661-672. doi: 10.1007/s00420-025-02160-9. Epub 2025 Aug 14.
PubMed 40810742
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06484569
- Acronym / sponsor ID
- Uskudar12
- Conditions
- Work Injury, Work-related Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory.
Detailed description
The study will include workers between the ages of 18-60 who have neck pain and work at Ölmezler Textile Industry Trade limited company in Van province. Participants will be divided into two groups as experimental and control groups. All participants will receive ergonomic training. In addition, exercise training will be given to individuals in the experimental group. Exercises will be explained individually and will be supported with an exercise brochure. Craniosacral therapy will also be applied to the experimental group and a brochure will be given to teach joint protection principles. Participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. The given exercises will be followed with an exercise follow-up chart. An evaluation will be made before and after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: ControlThey will receive ergonomics training |
| exercise | Experimental | Other: Control, Other: exercise and cranio sacral therapyErgonomics training, exercise training and cranio sacral therapy will be applied |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between 18-60 years old
- Working full time
- Experiencing neck pain
Key exclusion criteria (4 listed)
- Being under 18 or over 60 years old
- Presence of diseases accompanying neck pain
- Exercise intolerance
- Working part time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe content of ergonomics training will include the definition of ergonomics, ergonomic positions and arrangements. Postural arrangements will be explained to patients individually and supported by a brochure. | Other | control, exercise |
| exercise and cranio sacral therapyPosture exercises Stretching exercises Strengthening Exercises In addition, deep tissue massage will be applied to increase blood circulation and cranio-sacral therapy will be applied to increase cerebrospinal fluid circulation. | Other | exercise |
Primary outcome
Bournemouth Neck Pain Survey
Time frame: 14 weeks
The survey consists of 7 questions. In addition to questions about pain and disability, it also includes questions about psychosocial issues. Each question is scored between 0 and 10. The highest score is 70, with a higher score indicating a higher level of disability. The content of the survey consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on daily life activities and social life, anxiety-depression level, kinesiophobia and coping with pain.
The Fremantle Neck Awareness Questionnaire
Time frame: 14 weeks
The questionnaire is a Likert-type questionnaire (0 = Never/Never feel like this, 1 = Rarely feel like this, 2 = Sometimes or sometimes feel like this, 3 = Often feel like this, 4 = Always or most of the time feel like this) that evaluates individual-specific altered perception. The questionnaire asks individuals 9 questions such as how they perceive their neck in relation to their body, how they perceive their body position. The total score varies between 0-36. A high score indicates a poor prognosis.
Fatigue Severity Scale
Time frame: 14 weeks
The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.
Pittsburgh Sleep Quality Survey
Time frame: 14 weeks
The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 35604168Islam T. Health Concerns of Textile Workers and Associated Community. Inquiry. 2022 Jan-Dec;59:469580221088626. doi: 10.1177/00469580221088626.
- Background: PubMed 37299843Michaud F, Pazos R, Lugris U, Cuadrado J. The Use of Wearable Inertial Sensors and Workplace-Based Exercises to Reduce Lateral Epicondylitis in the Workstation of a Textile Logistics Center. Sensors (Basel). 2023 May 27;23(11):5116. doi: 10.3390/s23115116.
- Background: PubMed 20040992Metgud DC, Khatri S, Mokashi MG, Saha PN. An ergonomic study of women workers in a woolen textile factory for identification of health-related problems. Indian J Occup Environ Med. 2008 Apr;12(1):14-9. doi: 10.4103/0019-5278.40810.
- Background: PubMed 23411645Eraslan U, Gelecek N, Genc A. Effect of scapular muscle endurance on chronic shoulder pain in textile workers. J Back Musculoskelet Rehabil. 2013;26(1):25-31. doi: 10.3233/BMR-2012-0346.
- Background: PubMed 6242064Split W, Kotwica S, Woszczak M. [Role of exercise therapy in the prevention of lumbosacral backache in textile industry workers]. Med Pr. 1984;35(6):465-9. Polish.
- Derived from this study: PubMed 40810742Atasoy H, Sevgin O, Karamancioglu B, Dikmen Hosbas B. Ergonomics training with exercise and manual therapy in textile workers: a randomized controlled trial. Int Arch Occup Environ Health. 2025 Sep;98(7):661-672. doi: 10.1007/s00420-025-02160-9. Epub 2025 Aug 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal ATASOY study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and cranio sacral therapy in people with Work Injury and Work-related Illness, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bournemouth Neck Pain Survey (time frame: 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484569, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.